Procedure for permitting biosafety research facilities (Level 3 and 4)

Procedures for the approval of biological safety research facilities (Level 3 and 4)

If you wish to develop and experiment with living modified organisms (LMOs) that have a high risk to human health based on a risk assessment of pathogenic microorganisms, you must obtain permission from the Director of the Centers for Disease Control and Prevention to operate a Level 3 and 4 biological safety research facility.

1
Submission of an application for permission to establish and operate research facilities, along with supporting documents

Submission

2
Review of the suitability of submitted documents and standards

Request for supplementation
3
Supplementation of materials

4
On-site inspection
5
Expert review
7
Installation and operation of research facilities (reconfirmation every 3 years)

6
Notification of the review results

[Processing procedure]

Submission documents for the approval of biosafety level 3 and 4 research facilities

제출서류 - 신규허가, 변경허가, 폐쇄신고
Documents to submit
New permit	Application letter for the permit, facility permit application form (as per Enforcement Rules of the LMO Act, government revenue stamp (100,000 KRW)), supporting documents Facility design documents (floor plans) or copies thereof Documents proving the scope of the facility and ownership or usage rights (copy of business registration certificate, building register, lease contract for rental facilities) Basic design documents for safety prevention facilities Documents of inspection and verification results for the handling facilities of each item below A. Level 3 and 4 installation and operation inspection results (as per the notice form) B. Pre-inspection report before facility verification (including calibration certificates for measuring equipment) C. Verification results of the facility’s physical containment measures D. Verification results for research support facilities such as plumbing, electricity, and gas E. Results of air conditioning and exhaust system verification F. Results of barrel waste disposal system verification G. Results of the double-door high-pressure steam sterilizer verification H. Results of biological safety cabinet verification I. Results of animal housing equipment verification (where applicable) J. Results of biological safety cabinet-style glove box verification (where applicable) K. Results of verification of built-in equipment necessary for sealing and operation of other facilitie Institutional biosafety guidelines, including self-biosafety management regulations and facility operation procedures Status of research personnel and technical capabilities
Change permit	Changes to the permit application Changes to the physical structure of the facility Changes to the air conditioning and ventilation system, wastewater treatment system, and automated control system Installation or removal of double-door high-pressure steam sterilizers and major biosafety equipment Changes in the handling of LMO, animals, and facility usage Change request letter (institution approval), application form for change permit (as per the Enforcement Rules of the LMO Act), supporting documents Original biological safety facility installation and operation permit Installation and operation inspection results report (attached form of the announcement) Documents proving the changes (e.g., change drawings (comparison drawings before and after), change report (comparison photos and verification-related), revised operation guidelines (operation guidelines reflecting the changes))
Change notification	Items for change report Institution name, representative Installation and operation responsible person, biosafety management responsible person, biosafety manager Change report letter (institution approval), application form for change permit (as per the Enforcement Rules of the LMO Act), supporting documents Original biological safety facility installation and operation permit Report of installation and operation inspection (attached form of the announcement) Documents proving the changes (e.g., business registration certificate, graduation certificate, training completion certificate etc.)
Closure report	Closure report letter (institution approval), facility closure report form (as per the Enforcement Rules of the LMO Act), supporting documents Original biological safety facility installation and operation permit Documents proving the disposal details (e.g., facility decontamination results, pathogen disposal, treatment results, waste disposal results, committee meeting results, etc.)

The relevant form is attached in the Library [View form].

- Guidelines for the installation and operation of biosafety level 3 and 4 facilities, safety management guidelines for biosafety level 3 and 4 facilities, verification guidelines for biosafety level 3 and 4 facilities

Processing deadline

(If documents are incomplete, a request for supplementation will be made; submission within 30 days.)

New permit, change permit: Within 60 days
Change report, closure report: Within 10 days